Amicus Therapeutics Inc.says it is pursuing a broad label for full approval of its oral migalastat in Fabry disease after announcing that FDA rejected its plan for accelerated approval and called for a new trial.
Amicus Eyes Broad Future Label For Migalastat After Huge Filing Setback
US FDA recommends company start a new study of oral Fabry disease drug, to be designed using the agency's irritable bowel syndrome guidance for measuring efficacy in diarrhea.
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